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Factors Associated With The Risk of Post Tonsillectomy Hemorrhage

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ClinicalTrials.gov Identifier: NCT05280912
Recruitment Status : Recruiting
First Posted : March 15, 2022
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Hadeer Gamal Mohamed, Sohag University

Tracking Information
First Submitted Date February 18, 2022
First Posted Date March 15, 2022
Last Update Posted Date March 15, 2022
Estimated Study Start Date April 1, 2022
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2022)
new scoring system for possibility of post tonsillectomy bleeding [ Time Frame: after 4 weeks post tonsillectomy ]
investigators give a degree to the participants based on the factors they have as age and sex and accompanying to post tonsillectomy bleeding as increase white blood cells and anemia
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Factors Associated With The Risk of Post Tonsillectomy Hemorrhage
Official Title Factors Associated With The Risk of Post Tonsillectomy Hemorrhage
Brief Summary factors associated with increase risk of post tonsillectomy hemorrhage and score of associated factors
Detailed Description

investigators review the medical records of patients who underwent tonsillectomy with or without adenoidectomy in our facility. None of the included patients had any known coagulopathy. The surgery was performed by several different surgeons, either otolaryngology residents or specialists, and using either cold or bipolar dissection. The procedures were performed under general anesthesia with orotracheal intubation. Bipolar electrocoagulation was used for hemostasis, as well as in some cases vicryl sutures. All medical records were reviewed according to age, gender, indications for tonsillectomy (tonsil hypertrophy causing upper airway obstruction, snoring or sleep apnea, chronic tonsillitis, peritonsillar abscess or suspected malignancy of the tonsils), coagulation profile [international normalized ratio (INR) and activated partial thromboplastin time values (aPTT)], type of surgery (tonsillectomy alone or adenotonsillectomy), surgical technique (cold or bipolar dissection), hemostasis method (bipolar electrocoagulation alone or electrocoagulation and sutures) and post-operative hemorrhage and its characterization. In this report, investigators will evaluate patients and collection of data to make a new scoring system that assesses patients according to several preoperative and postoperative factors to know the possibility of patients developing Post tonsillectomy hemorrhage. Post tonsillectomy hemorrhage is divided into two groups according to its severity: minimal hemorrhage that stopped spontaneously/after noninvasive treatment, and hemorrhage requiring reoperation for hemostasis revision in the operating room under general anesthesia.

Postoperative hemorrhage was defined as any bleeding requiring in hospital observation or treatment (medical, compression, cauterization under general anesthesia). Patients who did not seek medical attention (e.g., patients with blood-tinged sputum or only minor bleeding) were not included in the group with post-operative hemorrhage

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All cases complicated by post-tonsillectomy bleeding
Condition Bleeding Following Tonsillectomy (Disorder)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Wall JJ, Tay KY. Postoperative Tonsillectomy Hemorrhage. Emerg Med Clin North Am. 2018 May;36(2):415-426. doi: 10.1016/j.emc.2017.12.009. Epub 2018 Feb 10. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 14, 2022)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2023
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • Inclusion criteria : All cases complicated by post-tonsillectomy bleeding

    1. after elective or emergency tonsillectomy
    2. Primary Hge or secondary Hge
    3. regardless of age, the indication of surgery, surgical techniques
  • Exclusion criteria:

    1. patient who have preoperative inherited bleeding disorder
    2. Patients who did not seek medical attention (e.g., patients with blood-tinged sputum or only minor bleeding) riteria:
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: hadir GM Abd el megeed, resident 01029977533 hadeer_gamal_post@med.sohag.edu.eg
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT05280912
Other Study ID Numbers HGMohamed
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Hadeer Gamal Mohamed, Sohag University
Original Responsible Party Same as current
Current Study Sponsor Sohag University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Chair: waleed AH mohammed, professor sohag faculty of medicine
Study Chair: mohamed ER ahmed, doctor sohag faculty of medicine
Study Chair: khaled G dahy, doctor sohag faculty of medicine
PRS Account Sohag University
Verification Date March 2022